CDE drug review weekly report (August 9, 2015 to August 15, 2015)

1 in the review this week (2015.8.9-2015.8.15), 87 drugs (calculated by acceptance number) entered the review status, 76 chemicals, slightly less than last week, including 3 1.1, 1 1 1.3, 1 1 1.6, 2 2 2, 22 3.1, 2 3.3, 1 3.4, 1 5, 22 6, 15 imports The 3.1 and 6 categories that entered the queue for review this week were less than last week, while the imported drugs were much higher than last week In addition, there are 3 biological products for treatment and 2 biological products for prevention The key points are as follows: 1 Wa1-089 tablets: This product is a chemical medicine declared by North China Pharmaceutical Co., Ltd in category 1.1, including wa1-089 raw materials and 2 specifications of tablets At present, Xiaobian has not found any information about this 1.1-type chemical, and any known little partner can leave a message in the background 2 Dexketoprofen sustained release patch: Zhejiang Asia Pacific Pharmaceutical Co., Ltd is a new drug delivery way which is not listed at home and abroad Dexketoprofen is mainly used for mild to moderate pain, such as rheumatoid arthritis, osteoarthritis and other joint pain, as well as dysmenorrhea, toothache, postoperative pain and so on At present, only its oral preparation, after changing the way of administration and making slow release, has the characteristics of longer duration of efficacy, lower side effects, convenient administration and so on 2 on approval In this week, a total of 18 drugs are in the approval status, all of which are chemical drugs Three of them (1.1) are the raw materials and capsules (fg-4592 capsules) of Beijing fabergin Pharmaceutical Technology Development Co., Ltd., three of them (3.1) are the raw materials and injections of bromomenatraxone of Shenyang Yiling Pharmaceutical Technology Co., Ltd and the tablets of rofluxide of Beijing SECCO Pharmaceutical Co., Ltd.) have been approved for clinical use In addition, sanfenamin orally disintegrating tablets, a class 3.2 chemical drug of Chongqing pharmaceutical industry Research Institute Co., Ltd., was also approved for clinical use 1 Kemei capsule: also known as fg-4592 capsule, chemical name is roxadustat, which is an effective second-generation selective HIF (hypoxia inducible factor) stabilizer for oral administration It was developed by fibrogen, and approved by anstelai and AstraZeneca At present, Kemei is in phase III clinical research stage in the world This product was first imported and declared by Beijing Fraiser Technology Co., Ltd in China, and obtained the clinical approval document in August 2010 In August 2014, Beijing Pharma Bojin Pharmaceutical Technology Development Co., Ltd applied for the clinical application of this product in category 1.1, which is a special approved variety After one supplement, it has also been approved for clinical application See Schedule 1 for the drugs under approval 3 The approval is completed For the drugs that have not been approved this week, all the teachers are busy with other things There are 22 drugs approved this week, including 20 chemicals, 1 biological product for treatment and 1 auxiliary material for medicine Including the 1.6 class new drug paclitaxel for injection (albumin binding type) of Shijiazhuang Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd previously introduced, the clinical approval has been completed; the clinical approval of cefotetan disodium and its powder injection of Jinan Blue Sea Chemical Co., Ltd has also been completed See attached table 2 for the chemical drugs after the completion of the preparation Attached: